EUCTR2021-002395-39-NL招募中1 期
A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER BASKET STUDY TO EVALUATE THE EFFICACY, SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF SATRALIZUMAB IN PATIENTS WITH ANTI-N-METHYL-D-ASPARTIC ACID RECEPTOR (NMDAR) OR ANTI-LEUCINE-RICH GLIOMA-INACTIVATED 1 (LGI1) ENCEPHALITIS
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 152
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Reasonable exclusion of tumor or malignancy before baseline visit (randomization)
- •Onset of autoimmune encephalitis (AIE) symptoms <=9 months before randomization
- •Meet the definition of New Onset or Incomplete Responder AIE
- •For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use adequate contraception during the treatment period and for at least 3 months after the final dose of satralizumab or placebo
- •For participants enrolled in the extended China enrollment phase at China's sites: participants who are current residents of mainland China, Hong Kong, or Taiwan, and of Chinese ancestry
- •N-methyl-D-aspartic acid receptor (NMDAR) AIE Cohort
- •Age >=12 years
- •Diagnosis of probable or definite NMDAR encephalitis
- •Leucine-rich glioma-inactivated 1 (LGI1) AIE Cohort
- •Age >=18 years
- •Diagnosis of LGI1 encephalitis
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 16
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 96
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •Any untreated teratoma or thymoma at baseline visit (randomization)
- •History of carcinoma or malignancy, unless deemed cured by adequate treatment with no evidence of recurrence for >=5 years before screening
- •For patients with NMDAR AIE, history of negative anti-NMDAR antibody in cerebrospinal fluid (CSF) using a cell-based assay within 9 months of symptom onset
- •Historically known positivity to an intracellular antigen with high cancer association or GAD-65
- •Historically known positivity to any cell surface neuronal antibodies other than NMDAR and LGI1, in the absence of NMDAR and LGI1 antibody positivity
- •Confirmed paraneoplastic encephalitis
- •Confirmed central or peripheral nervous system demyelinating disease
- •Alternative causes of associated symptoms
- •History of herpes simplex virus encephalitis in the previous 24 weeks
- •Any previous/concurrent treatment with IL-6 inhibitory therapy (e.g., tocilizumab), alemtuzumab, total body irradiation, or bone marrow transplantation
- •Any previous treatment with anti-CD19 antibody, complement inhibitors, neonatal Fc receptor antagonists, anti-B-lymphocyte stimulator monoclonal antibody
- •Any previous treatment with T-cell depleting therapies, cladribine, or mitoxantrone
- •Treatment with oral cyclophosphamide within 1 year prior to baseline Treatment with any investigational drug (including bortezomib) within 24 weeks prior to screening
- •Concurrent use of more than one IST as background therapy
- •Contraindication to all of the following rescue treatments: rituximab, IVIG, highdose corticosteroids, or intravenous (IV) cyclophosphamide
- •Any surgical procedure, except laparoscopic surgery or minor surgeries within 4 weeks prior to baseline, excluding surgery for thymoma or teratoma removal
- •Planned surgical procedure during the study
- •Evidence of progressive multifocal leukoencephalopathy
- •Evidence of serious uncontrolled concomitant diseases that may preclude patient participation
- •Congenital or acquired immunodeficiency, including HIV infection
- •Active or presence of recurrent bacterial, viral, fungal, mycobacterial infection, or other infection
- •Infection requiring hospitalization or treatment with IV anti-infective agents within 4 weeks prior to baseline visit
- •Positive hepatitis B (HBV) and hepatitis C (HCV) test at screening
- •Evidence of latent or active tuberculosis (TB)
- •History of drug or alcohol abuse within 1 year prior to baseline
- •History of diverticulitis or concurrent severe gastrointestinal (GI) disorders that, in the investigator’s opinion, may lead to increased risk of complications such as GI perforation
- •Receipt of live or live-attenuated vaccine within 6 weeks prior to baseline visit
- •History of blood donation (1 unit or more), plasma donation or platelet donation within 90 days prior to screening
- •History of severe allergic reaction to a biologic agent
- •A history of suicide attempt within 3 years prior to screening except if this is clearly associated with and occurs during the acute phase of LGI-1 or NMDAR encephalitis
- •Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes safe participation in and completion of the study
- •Pregnant or breastfeeding, or intending to become pregnant during the study or within 3 months after the final dose of study drug
- •Laboratory abnormalities at Screening
研究者
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